FDA panel says benefits of Endo's Opana ER no longer outweigh risks

An FDA advisory committee voted 18 to eight with one abstention that the benefits of Endo International's reformulated Opana ER (oxymorphone) no longer outweigh its risks. The agency convened the meeting to discuss pre- and post-marketing data about the abuse of Opana ER, as well as the product's overall risk-benefit profile.

Opana ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The drug was initially approved by the FDA in 2006, with a new formulation designed to deter abuse reaching the market in 2012. However, in August last year, Endo decided to withdraw a marketing application concerning specific abuse-deterrent labelling for Opana ER following discussions with the FDA.

According to FDA reviewers, data show that while nasal abuse has reduced with the reformulated version of Opana ER, rates of intravenous abuse increased, acknowledging that it was unclear whether that rise was tied directly to the reformulation. The agency staff added that this trend was apparent before the reformulation was launched, and abuse rates are similarly high for generic versions of oxymorphone.

At the advisory committee meeting, some panelists also expressed concerns that the voting question posed by the FDA did not expect them to evaluate the risk-benefit profile for the intended user, versus an addict. Panel member Ronald Litman noted that as long as oxymorphone remains on the market, Opana ER will still benefit patients, because otherwise they'll just switch to generic oxymorphone that has no abuse-deterrent properties. "I voted yes, but I strongly believe there is no place for oxymorphone in American society today - but that's not what you asked me," Litman added.

In response to the vote, Endo said it "will evaluate the range of available options for maintaining access for legitimate use."